Objective: The paper attempts to explore the value of Real-World Data (RWD) in the assessment of medical insurance access for new indications of multi-indication drugs, and to provide guidance for improving China’s medical insurance pricing mechanism for such medicines. Methods: A systematic review was conducted of the mechanisms and approaches used in Germany, France, Italy and Japan for applying RWD in the assessment of medical insurance access for new indications of multi-indication drugs, and an analysis was carried out of China’s current policies and the current status of RWD application. Results: The four countries adopted distinct approaches to the application of RWD: Germany utilises RWD to supplement clinical evidence, supporting the re-evaluation of additional therapeutic benefits and adjustments to reimbursement amounts; France uses RWD to calibrate projected usage volumes, enabling dynamic adjustments to payment standards; Italy employs RWD to validate treatment responses as defined in outcome-based agreements, underpinning differentiated net payments at the indication level; and Japan utilises real-world sales data to drive periodic price adjustments through a volume-price linkage mechanism. China’s current “one generic name, one reimbursement standard” model struggles to reflect differences in clinical value across different indications, whilst the application of RWD remains primarily focused on cost monitoring, facing the dual challenges of “a lack of value assessment dimensions” and “insufficient RWD evidence”. Conclusion: It is recommended to establish a mechanism for indication-specific value assessment and categorised management, to refine the mechanism for adjusting differentiated reimbursement standards based on value assessment outcomes, to strengthen institutional support for the use of RWD in pricing new indications, and to advance the development of infrastructure for refined medical insurance management at the indication level.
Key words
real-world data /
multi-indication drugs /
new indication /
medical insurance access /
experience
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